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Hi Jim- it sounds like a promising venture. I'd like to get involved in some aspect. On the website that you posted, it states that FDA approval could be sought by mid-2010. With adequate funds are trials possible this year?

Chaz, we will be training the investigators and initiating a 6-month observational trial this fall. The treatment phase of the trial begins in Q3 of 2010. We have set a very ambitious schedule of raising the funds, obtaining regulatory approval, organizing and training the centers, and recruiting the subjects in the coming 6 months. We developed the observational trial approach in the ChinaSCINet to obtain repeated examinations of the subjects over a 6 month period before initiating treatment.

I agree, let's get started. It's about time we do something as it relates to chronic SCI human clinical trials. Why would the Christopher Reeve foundation not be interested in helping with this? After all aren't they the figure head of our community with the public at large?

The question I have is why do we need to setup a new,different or seperate clinical trial network? What network is Geron going to use? What happened to http://www.christopherreeve.org/site...al_Network.htm ? I can't get the link to work, click on research on the home page , scroll down to clinical trials on the lower left of the screen and look for "Reeve Foundation North-American Clinincal Trials Network"

With times as tough as they are and money hard to come by shouldn't we be pooling our resources?

RJames,

I think that we need to have as many clinical trials as possible. At least two companies have announced clinical trials of subacute spinal cord injury: Geron (embryonic stem cells) and Alceres (Cethrin).

NACTN is currently studying the natural course of spinal cord injury in the first 12 months (Source) and, since 2009, they are planning to test riluzole treatment of acute spinal cor dinjury (Source).

NASCINet is focused on chronic spinal cord injury, which we define as more than a year after injury and at least 6 months of stable neurological status. NASCINet will be initially doing trials in parallel with ChinaSCINet, assessing umbilical cord blood mononuclear cell transplant and lithium.

Somebody asked for the names of centers that are involved in NASCINet. So, far, we are discussing the clinical trial with the following organizations:

• New Jersey Medical School and Kessler Institute of Rehabilitation.
• Thomas Jefferson School of Medicine and Magee Rehabilitation.
• Shriner's Hospital in Philadelphia
• Brackenridge Hospital in Austin
• Mt. Sinai Hospital in New York City
• Long Island Jewish Hospital in Long Island
• Shepard Rehabilitation Center in Atlanta, Georgia
• Wayne State University in Detroit, Michigan
• University of Colorado in Denver

I want to emphasize that this is still at the stage of "discussion". We are having investigator meetings right now, exploring what can and cannot be done. The trials have been proposed to the investigators and we have had substantitive discussions. There are still major obstacles that must be overcome, including finalizing the clinical trial protocol, application for regulatory approval, training and vetting of the centers, and successful fundraising.

I am in China now and about a dozen investigators from the centers will be attending meetings in Beijing and Kunming, to see what is being done in China and to participate in a consensus conference to determine the rehabilitation protocol can and should be in the United States for the trial.

I am renaming this topic to North American Spinal Cord Injury Network and sticking it, so that it can become a resource. I am getting a lot of the same questions asked over and over again. People should also check out http://nascinet.org

Dr. Young
The plan of having actual clincial trials in the US that provide a treatment for chronic injury is very exciting.
Your saying the first phase would be 6 months of observation of people standing?
I don't understand the reason for this, maybe I am missing something.
How much would that cost and couldn't that money raised be better used to go to an
actual treatment phase trial?

Somebody asked for the names of centers that are involved in NASCINet. So, far, we are discussing the clinical trial with the following organizations:

• New Jersey Medical School and Kessler Institute of Rehabilitation.
• Thomas Jefferson School of Medicine and Magee Rehabilitation.
• Shriner's Hospital in Philadelphia
• Brackenridge Hospital in Austin
• Mt. Sinai Hospital in New York City
• Long Island Jewish Hospital in Long Island
• Shepard Rehabilitation Center in Atlanta, Georgia
• Wayne State University in Detroit, Michigan
• University of Colorado in Denver

I want to emphasize that this is still at the stage of "discussion". We are having investigator meetings right now, exploring what can and cannot be done. The trials have been proposed to the investigators and we have had substantitive discussions. There are still major obstacles that must be overcome, including finalizing the clinical trial protocol, application for regulatory approval, training and vetting of the centers, and successful fundraising.

I am in China now and about a dozen investigators from the centers will be attending meetings in Beijing and Kunming, to see what is being done in China and to participate in a consensus conference to determine the rehabilitation protocol can and should be in the United States for the trial.

Wise.

Thanks, Wise! I gotta say, I was hoping to see at least one west coast hospital on that list, but I'm sure there are reasons why not. In any case, it's super good news.

NASCINet is focused on chronic spinal cord injury, which we define as more than a year after injury and at least 6 months of stable neurological status. NASCINet will be initially doing trials in parallel with ChinaSCINet, assessing umbilical cord blood mononuclear cell transplant and lithium.

Chaz, we will be training the investigators and initiating a 6-month observational trial this fall. The treatment phase of the trial begins in Q3 of 2010. We have set a very ambitious schedule of raising the funds, obtaining regulatory approval, organizing and training the centers, and recruiting the subjects in the coming 6 months. We developed the observational trial approach in the ChinaSCINet to obtain repeated examinations of the subjects over a 6 month period before initiating treatment.

Wise.

Hallo Dr.Young
You are busy with this reaserch in China, why you are repeating the same trial? is it not better to use the money and energy to test another kind of possible treatment??
Fr. regards

Chaz, we will be training the investigators and initiating a 6-month observational trial this fall. The treatment phase of the trial begins in Q3 of 2010. We have set a very ambitious schedule of raising the funds, obtaining regulatory approval, organizing and training the centers, and recruiting the subjects in the coming 6 months. We developed the observational trial approach in the ChinaSCINet to obtain repeated examinations of the subjects over a 6 month period before initiating treatment.

Wise.

This sounds very exciting. I'll stay tuned on this thread for further information. Thank you.